Tuesday, 29 March 2016

The issue of the 2 million substandard vaccines distributed across China continues to make waves in the media and for the government, with some surprising developments.

In a bold move, a group of more than 40 lawyers has written an open letter to the State Council demanding that the government 'protect the public's rights to information and compensation' in regard to the health consequences of the illegal vaccines. In their letter, they pose five questions:

How do individuals know if they have received the substandard vaccine?

How can people find out whether the vaccine they received was effective, and if necessary the need to re-vaccinate - and who will bear the cost?

Why were the public not informed of these risks associated with vaccination?

Why did the vaccine quality monitoring system set up in 2006 fail in early warning?

For those with vaccine injury, how will this be remedied?

According to Caixin, one of the authors of the letter is Guangdong lawyer and mother of a baby Wang Shengsheng. She herself got one of the suspect vaccines for hepatitis B and was shocked to discover that she may have put her baby at risk.

Wang Shengsheng says she had her baby vaccinated with both essential and non-essential vaccines on the strong recommendation of health authorities and was told they were both necessary and safe. She says she now expects full and prompt disclosure of all results from the investigation, particularly in relation to the batch numbers and locations of the affected vaccines. She says there is also a need for authorities to learn lessons from this scandal so that health consumers can be confident about future treatments and thus have the right to 'informed consent'. This freedom of information should include access to adverse event reports for individual vaccines that are derived from vaccine monitoring programs, she said.

Wang Shengsheng said China also needed a system of compensation for patients with recognised vaccine-related injuries, similar to the system already operating in the US.

Meanwhile, Chinese media outlets such as Sohu Health are reporting that parents are staying away from vaccination clinics as they have lost confidence in the safety and quality of the vaccines being offered.

Reporters who visited community health centres in Guangzhou found them almost empty, and with the few families there expressing concerns about the vaccines being used.

A doctor on duty at a clinic in Tongling said: "Usually at this time we should be full of people. But many parents do not dare vaccinate their children at this time. For the last two days we have been calling people telling them that our vaccines are safe but they are still reluctant to come. They say they are waiting for this matter to blow over."

A doctor at the Zhejiang Tonglu Street Community Health Centre told reporters that they had received dozens of calls from concerned parents asking about the quality and safety of the vaccines they had received. He said parents were still bringing in children to have the essential (Class 1, public funded) vaccines that were not part of the scandal, but use of the Class 2 (private market) vaccines had really dropped.

Doctors at other community clinics were emphasising to worried families that their region's vaccine supplies were on the 'safe list' as they were still part of the public centralised system that had always been well supervised and had not been implicated in purchase of substandard vaccines. They said they were now glad that the vaccine supply and distribution had been kept under control of the government disease control bureau and not 'relaxed' and privatised, as had been the case for many rural counties.

An opinion article in Caixin said the substandard vaccine scandal showed the stark contrast between China's successful and safe public vaccine program and the corrupt and unsafe 'private market' vaccine supply system. The article said the 2006 decision to relax controls on the sale and supply of 'optional' vaccines (Class 2) to allow a free market system had backfired with disastrous consequences for public health.

The article describes how local communicable disease control (CDC) bureaus had been encouraged to 'go to market' to generate extra funds for their own running costs. As with hospitals, these local units had been starved of funding and therefore came to rely on commissions from vaccines to boost their income. This resulted in local CDC bureaus buying the cheapest possible vaccines and charging the maximum markup to patients. It also meant that they strongly recommended non-essential vaccines to families, so that they could make extra profit.

Therefore, any reform to prevent further substandard vaccine incidents will need to address the "vaccine commission cash cow" phenomenon as well as ensuring the quality of the vaccine distribution system, it concludes.

Monday, 28 March 2016

by MICHAEL WOODHEAD
It is quite remarkable that in the middle of the second week of the scandal around distribution of dud vaccines there has been no comment whatsoever from China's health minister Li Bin. In fact the response from the Chinese government could be summed up as an attitude of "Crisis? What crisis?"

The official line has been to focus on the perpetrators - the illegal wholesalers and distributors in Shandong - and to avoid any analysis of how things could go so badly wrong - and what the Chinese public should do about it all.

It seems clear that the government has been 'harmonising' (deleting and censoring) media and online articles and social media discussions relating to the vaccine scandal. The media articles that originally drew attention to the crisis have been removed, and instead replaced with bland assurances from officials that the matter is being investigated and all should be well.

Most of the permitted coverage has been along the lines of the WHO China response, namely:

The dud vaccines are unlikely to cause any adverse effects even if not handled according to the cold chain.

Most of the vaccines have already been used, and there have been no reports of spikes in adverse events.

The illegal distribution is being investigated and the perpetrators brought to justice.

That's it.

There has been no response to important questions such as:

How many people received dud vaccines and have any of them acquired diseases because of poor immune protection?

What are the most frequent and potentially most severe diseases covered by the dud vaccines?

What needs to be done to trace/follow up/test and re-vaccinate those who have received dud vaccines?

How can the public be reassured that vaccines currently in the system are not duds? Batch numbers? Locations?

These are just a few of the fundamental questions that any professional and competent medical regulator such as the FDA would be asking. And yet in China there has been no such response. There have been some vague reassuring statements from the China FDA, but no detailed information about the scale of the problem and how it will be addressed.

Once again the "SARS hero" Dr Zhong Nanshan has been given airtime to comment. Speaking at a national influenza conference in Hainan (unfortunate timing) Dr Zhong said there was no need to doubt the quality of Chinese made vaccines and no reasons for panicked parents to seek foreign vaccines or to go to places such as Hong Kong for vaccinations. He also said (quite rightly) that he hoped the vaccine scare would not undermine China's immunisation program, which has markedly reduced or eradicated diseases such as measles, whooping cough, polio and hepatitis B in China.

Fine words, and not to be disputed, but there is a need for more leadership on this issue if public faith in the public vaccination system is to be restored. As I've said before, trust is not easily won and it is a two-way street. If the government does not trust the public with information - if it closes down the communication channels and deletes articles about the vaccine problems then it will just encourage the public to turn to the rumour network.

On a wider level there is little hope for a robust medical and healthcare safety system when there is a culture of punishing those who speak out. In other countries there has been grudging acceptance by authorities that transparency and accountability are needed in clinical matters to ensure safety. Staff have to feel confident that they can speak out - and also feel that it is their duty to do so, rather than feel intimidated or a false sense of loyalty to persons or organisations. In China under Xi Jinping there is currently a major crackdown on those who are outspoken or who dare to question "the core".

And so at the end of March we find that China is facing its biggest health safety crisis since the melamine in milk saga of 2011. And yet if you turn to the medical forums such as DXY.cn there is no discussion and no advice there. They have presumably also been 'harmonised'. A week ago when the scandal first became public, the Deputy director of the Department of Immunology at Peking University Professor Wang Yue expressed shock at the safety implications of the dud vaccine trading.

"This is murder" he said, referring tho the likelihood of people dying from vaccine preventable diseases.

The article has now been taken down.

It's important for Li Bin to show some leadership and act swiftly to restore the public's faith in China's vaccination system. If not, vaccines may become like China's milk formula industry - untrusted, shunned and encouraging consumers to turn to expensive alternative 'grey market' suppliers.

Thursday, 24 March 2016

by MICHAEL WOODHEADThe expired vaccine 'shame' originating in Shandong has caused a huge outcry of concern in China and has prompted angry reactions from the very top leaders, including Li Keqiang.

Here's what we know so far:

1. More than 2 million doses of expired or spoiled vaccine worth $88 million have been sold by a rogue Shandong wholesaler since 2011.

2. Between 12 and 25 different vaccine products were involved. They were Class 2 (non-essential/optional) vaccines such as rabies and Japanese encephalitis, which are distributed via private wholesalers rather than though the centralised buying system used for Class 1 (essential/state-funded vaccines). The vaccine products affected are said to include:

Rabies, Rabies immune globulin

Varicella,

Haemophilus influenza B (Hib),

Pneumococcal polysaccharide vaccine (23-valent)

Meningococcal A/C vaccine

Influenza vaccine,

Hepatitis B vaccine

3. The mother and daughter team of rogue sellers have been arrested, along with 37 other suspects in Shandong. They are believed to have bought cheap vaccines that had expired or had not been stored or transported according to cold chain methods to ensure they remained viable. Three pharmaceutical companies have been investigated and one has had its manufacturing and distribution suspended. A further nine wholesalers are under investigation.

4. The National Health and Family Planning Commission and the China FDA say they are now "resolutely investigating the relevant departments" and actively tracking down where the vaccines have been sold to 24 provinces. Officials say each vaccine and recipient should be traceable by barcode and batch number. Authorities are now investigating the case at the behest of Premier Li Keqiang, who has called in law enforcement authorities and said there were obvious loopholes in the regulatory system for the supply and distribution of Class 2 vaccines.

5. The WHO say that there should be no major adverse effects in recipients of vaccines that have expired or not been handled according to the cold chain procedures - however the recipients may not have received an adequate immune response and would not be protected against the infections for which the vaccine was given. The WHO has urged the Chinese public to maintain faith in the immunisation system and it emphasises that vaccination programs have helped reduce China's high burden of infectious diseases.

6. The NHFPC says there have not been any notable spikes in vaccine related adverse effects but it is now checking figures - particularly for the Shandong area.

7. Chinese netizens are asking why the information was only brought to light in February 2016 when the authorities became aware of the problem in April 2015. This raises obvious questions of whether vaccines could have been traced and recalled before being given to unsuspecting patients.

8. There has been public outrage and 'vaccine panic', with many Chinese expressing scepticism about the quality of Chinese made and distributed vaccines and anger about the integrity of the medical safety surveillance and regulatory system. There are fears for vaccination rates may fall as the public lose faith in public vaccine programs.

9. Some of the more open media outlets have blamed China's lax approach to food and medicine safety on the authorities' lack of accountability and transparency and also the routine censorship of and control of 'bad' news. Caixin magazine ran a feature that harked back to a previous hepatitis B vaccine adverse events scandal from 2013, but the article was later deleted.

10. Some analysts have said that the Class 2 non-essential vaccine distribution system is ripe for corruption. It has minimal regulation and there are strong financial incentives for unscrupulous wholesalers and local disease control departments to collude to make commissions and backhanders off sales of unreliable vaccines.

11. China CDC director Wang Huaqing says that after a full investigation some children and adults may need to undergo repeat vaccinations to ensure they are covered against certain diseases. However he says the more widespread impact is likely to be on herd immunity levels in the population rather than individual risk of infection.

Wednesday, 23 March 2016

A letter in Lancet Global Health this week from urologist Dr Guan Xiao and colleagues at the Xiangya Hospital, Changsha, Hunan:

On Jan 15, 2016, the National Health and Family Planning
Commission of China reported its work plan for 2016 at a press
conference in Beijing, mentioning that it will expand the public
hospital reform to 200 cities in China.
The core part of the reform is to ban the price increase of drugs and
materials, reduce the cost of medical examinations, and appropriately
raise the price of medical services provided by physicians, such as
surgery.

However, under this circumstance, public
hospitals in China are now in the dilemma of whether to choose
reasonable hospital operational costs or public welfare. With the
increasing demand for health-care services, the operational cost of
hospitals will inevitably increase. For public hospitals, drug sales
account for about 40% of their revenue, and medical income (eg, from
examinations, laboratory tests, and operations) brings in about 49%.2
With the ban on charging extra for drugs and materials, as well as the
reduced cost of examinations, hospitals' revenue is likely to reduce.
Although the income from medical services will increase, this factor is
far from enough to offset the operational cost, which will result in a
great reduction in many public hospitals' gross revenue, even leaving
some hospitals at a financial loss. According to some health insurance
policies, there are limits on how much a patient can spend on their
treatment. If the total cost exceeds the limit, then the hospital might
not get the balance from the health insurance department. Because of
these health insurance issues, hospitals have no choice but to reduce
the use of expensive but effective drugs and materials. However, this
move could compromise the quality of medical services.

The
government's subsidy accounts for only about 8% of public hospitals'
revenue, putting these institutions under great pressure.
Public hospitals have to seek new ways to make a profit instead of only
sticking to their public welfare goals. The government has lowered
medical costs in response to public demand; however, the subsidy remains
the same. To solve the dilemma hospitals are now facing, the government
should increase the subsidy to a level that is enough to cover
operational costs without damaging the medical staff's initiative.
Investment in health-care services takes up only about 6% of finance
expenditure in China,
compared with about 15% in developed countries. Additionally, the
adjustment of the prices of medical services is lagging far behind the
market prices. The mechanism of adjustment for these prices should be
revisited.

People could benefit a lot from the launch of
the public hospitals reform. For public hospitals, it is not a simple
choice of choosing survival of the organisation or public welfare. We
should find balance between them.

Monday, 21 March 2016

At least two million doses of spoiled vaccine have been traded by rogue wholesalers
based in Jinan Shandong. Health authorities in the province say they
are trying to track down the vaccines, which were sold by a mother and
daughter criminal gang despite being past their expiry date or having
failed cold chain storage and handling procedures. The vaccines, worth
at least half a million yuan, were for conditions such as influenza,
hepatitis B, and were sold to many provinces including Hubei, Anhui,
Guangdong, Henan, and Sichuan. The scandal is seen as a major failure of
provincial and national drug regulatory authorities.

The first vaccine against hand-foot-and-mouth disease (HFMD) caused by enterovirus 71 (EV71), has been launched by a Chinese company. The Institute of Medical Biology, Chinese Academy of Medical Sciences, says the China FDA approved the production of the vaccine in December, 2015.

A new national survey has found poor morale among China's doctors, with 87% saying they would not want their children to enter the medical profession. The survey of doctors in 31 areas found that 80%of doctors believed the fees and remuneration were far too low, and wanted them raised to reflect their true value. About two thirds of doctors believed they were overloaded at work, and only 34% felt they got sufficient sleep.

At the NPC Premier Li Keqiang says one of his priorities is to achieve national portability of medical insurance schemes at a faster pace. He also plans to cut red tape to make it easier for retired people to claim medical insurance benefits away from their hometown and for aged care homes to offer medical services. Meanwhile. health minister Li Bin said her priorities were to cut out hospital ticket scalpers and to have a phased and orderly introduction of the Two Child Policy.

Hong Kong's largest chain of private health clinics, Human Health Holdings Ltd says it plans to open clinics on the mainland.
The company is offering shares and says it plans to use the revenue to
open clinics in China's major cities over the next three years. It
partnered with China Ping An Insurance Holdings to open its first clinic
in Shanghai last year.

Sunday, 20 March 2016

China has one of the highest rates of caesarean section in the world, and China's health ministry has for years been paying lip service to the idea that this is not such a good thing and that vaginal births should be encouraged.

However a recent in-depth investigation of birth practices in Shanghai by a joint team of US and Chinese obstetrics researchers found that the practice of caesarean section has become entrenched in the system as the norm and little effort is being made to tackle the situation.

The investigation, led by Dr Susan Hellerstein of Harvard Medical School and Brigham and Women's Hospital, found that caesarean section was being encouraged by the hospitals as a way of coping with the huge workload of birthing mothers (16 million babies are born in China every year, 200,000 in Shanghai alone). The high rates of caesarean section were also being driven by mothers wanting a quick and 'safe' birth on a lucky day, and also driven by hospitals wanting to avoid medical disputes with patients.

The end result is that China's hospitals are simply not set up to allow women to have vaginal births - the obstetric hospitals do not have labour rooms and do not have the staff to allow women to give birth by labour rather than by caesarean.

As part of their investigation the team, which included Professor Tao Duan, Director of Shanghai Woman's Healthcare Institute, visited five public hospitals and one private (VIP) hospital in Shanghai. They asked many questions both of women and of the medical staff.

They found that Shanghai has a three tier obstetrics system. The highest tier is the so-called VIP private system, which functions at the one top end private hospital with exhorbitant fees by Chinese and international standards (about US$19,000 for a caesarean section birth).

The second - and largest - tier is the Shanghai public hospital system for city residents. This offered a basic obstetrics package, which usually involved a scheduled caesarean and two days of recovery, for a cost of about $1000. Most of this was in theory claimable on the health insurance that is provided by employers. (Some public hospitals offered 'VIP packages' and add-ons at a cost of $5000).

The third tier is the migrant workers' obstetric hospital network. These basic clinics offer a minimal obstetrics service for about $300.

The investigators found that women have to pay upfront for all services and then claim back what they can from any insurance that they have. In practice, this often means women have to queue for long periods to register and pay for each of their antenatal visits.

One of the most striking things the US researchers noticed about the Chinese maternity hospital system was the high number of patients and low numbers of staff. It was quite normal for a single obstetrics outpatient clinic to have 80-120 women scheduled in one eight hour day. Even the "VIP" services saw 40-60 patients a day. Although women got to have very little time to spend talking with the doctor, the researchers noticed that they tended to have more tests and investigations, which they found to be part of a 'defensive medicine' trend.

The high number of patients also put pressure on women to have caesarean sections - a typical birthing unit could expect to deliver eight babies in an eight hour shift, with each caesarean section taking about 30 minutes ( in contrast to vaginal birth taking from 4-24 hours). The average caesarean section rate observed in the Shanghai hospitals was 66%. The women who did have a vaginal birth did so alone (family are not permitted to be present at the birth) and without the aid of analgesics - no epidurals! Women usually had to share a maternity ward with up to four other women and did not have any personal or emotional support from either nurses or doctors.

New mothers are allowed to stay in the hospital for two days of postnatal care after a caesarean section and four days after a vaginal birth. This time was deemed important to Chinese families so that the new mothers could avoid 'hot and cold', rest and consume traditional soups, the researchers found.

When the researchers interviewed mothers and doctors at the hospital they found several factors that encouraged caesarean sections. Firstly there was maternal preference - Chinese women did not want to go though the pain of vaginal birth and feared this would spoil their health and sexual function. They also preferred the convenience and speed of caesarean section, especially as it could allow them to have a baby on a lucky day. Most believed that caesarean section was safer.

The doctors interviewed also said that pressure from women and their families was a major factor in encouraging caesarean sections to be the norm. Most doctors expressed strong feelings about the risk of disputes with patients and their families over medical events, with more than 60% having had experience of serious medical disputes with patients - often physical. Doctors also conceded that there were 'system' pressures on them to provide caesarean sections - it was more efficient and financially lucrative for the hospital, and doctors' salaries were based on the number of women who were managed though birth every day.

It was also noticeable that obstetrics medical staff were very concerned about maintaining their high reputation and did not want to discuss errors and problems with their peers and certainly not with patients.

"The concept of protected open medical discussion of errors or poor outcomes, transparency with patients, and patient apology were neither well developed nor deemed culturally acceptable by most chiefs of services," they noted.

The researchers found that hospitals were geared up to provide caesarean sections as the main method of delivery - the ratio of operating suites to labour suites was 2:1, in contrast to maternity hospitals western countries where the ration is heavily in favour of labour units over operating theatres.

While the main part of the investigation was carried out in 2012, the US researchers returned in 2015 and found there had been no change to the maternity hospital setup.

"We observed that ... most public obstetric care did not meet rising patient expectations with ward style labor and delivery suites, lacking family involvement, pain control, and emotional support in labor. In the cosmopolitan environment in Shanghai, with advanced public transportation and ubiquitous high tech consumerism, the public health care system lagged significantly in development and appeared out of synch with other aspects of society."

They concluded that the high rate of caesarean sections is likely to continue in China's hospitals due to the high throughput' of women in the maternity system and the institutional factors that promote an 'efficient' rate of births. The high caesarean rate is also reinforced by societal and institutional pressures that put the emphasis on convenience and control in contrast to the untidyness and unpredictable nature of a spontaneous vaginal birth.